MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

NCT ID: NCT04430114

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2022-03-01

Brief Summary

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The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.

Detailed Description

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Conditions

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Aneurysm Abdominal Aneurysm Thoracic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TAAA spinal loop graft

Group Type EXPERIMENTAL

branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms

Intervention Type DEVICE

Jotec "TAAA spinal loop graft" "custom made CE equivalent" branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.

Interventions

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branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms

Jotec "TAAA spinal loop graft" "custom made CE equivalent" branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged ≥ 18 years;
* patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using "TAAA spinal loop graft" "custom made CE equivalent" prosthesis

Exclusion Criteria

• patients aged ≤ 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Bertoglio Luca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CLEOPATRA study

Identifier Type: -

Identifier Source: org_study_id

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